FDA.report

Henry Schein

Primary DI
20304040052840
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1010377
Catalog number
1010377
Device description
General Purpose Cleaner
Published
2020-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLGCleaner, ultrasonic, medical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040052840PackageGS16In Commercial Distribution
10304040052843PrimaryGS10
00304040052846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404005284020304040052840
1030404005284310304040052843
00304040052846003040400528463040400528460304040052846

GMDN Terms

TermDefinition
Ultrasonic water bathA mains electricity (AC-powered) device used for the cleansing of instruments/utensils using ultrasonic waves transmitted from its integral transducers through the water contained in the bath. A dedicated cleansing agent may be added to the water to enhance the cleansing effect.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
24
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187555Zirlux920005592000552026-02-04
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00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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